The Coalition has developed an aggressive plan to address the FDA’s recent “draft guidance” for including risk information in advertising and other marketing materials.
Under the leadership of Harry Sweeney, the Coalition has developed an aggressive plan to address the FDA’s recent “draft guidance” for presenting risk information in advertising and other marketing materials. (View the draft guidance.)
While the guidance largely restates current FDA policy, it comes down hard on the notion of ensuring equal time and space dedicated to risk and benefit
information, and on judging the suitability of materials on the basis of perceived “net impression”. By loading so much into the communication, the “net impression” could end up being confusion. This could dilute the educational value of the materials, and accordingly lead advertisers to lessen DTC expenditures.
The guidance could provide a mechanism for aggressive enforcement that would virtually preclude most marketing at the “preapproval” stage, again lessening the valuable exchange of important information and leading companies to further reduce their marketing spending.
Harry is seeking additional financial and other support for our efforts and will be discussing them at the Coalition meeting on July 23. Contact him with questions, and especially offers to participate. (firstname.lastname@example.org).
For a recent press view of the draft guidance, see this recent article in The Los Angeles Times. Although there is plenty to disagree with in the article and plenty the reporter does not understand, he clearly understands the danger posed by the FDA guidance. However, among other things, he completely misunderstands the First Amendment implications, assumes that a prescription written due to exposure to DTC is a bad thing, and does not take into account recent data that shows that DTC does not increase the cost of pharmaceuticals.
We encourage you to discuss this issue with us on the Coalition’s LinkedIn Group.